Rezolute, Inc. (Nasdaq: RZLT) is still in the spotlight on December 24, 2025, after a brutal mid-December selloff tied to its pivotal clinical trial news—and a wave of follow-on analyst downgrades, price-target resets, and investor-law-firm investigations. As of the latest available pricing around $2.42 per share, the stock is off its post-trial lows but remains dramatically below pre-readout levels, leaving investors weighing a simple question with complicated consequences: was sunRIZE a fatal blow, or a detour that shifts the story toward Rezolute’s next late-stage program? [1]
Below is a complete, publication-ready breakdown of the current RZLT stock news, forecasts, and analyses available as of 24.12.2025, focused on what moved the stock, what Wall Street is saying now, and what milestones matter next.
What happened to Rezolute stock: the Phase 3 sunRIZE trial failed its key goals
The core catalyst behind Rezolute’s collapse was the company’s December 11, 2025 announcement of topline results from sunRIZE, a Phase 3 study evaluating ersodetug for congenital hyperinsulinism (cHI). Rezolute said the study did not meet its primary endpoint (change in average weekly hypoglycemia events by self-monitored blood glucose) or its key secondary endpoint (change in percent time in hypoglycemia via continuous glucose monitoring). [2]
The headline numbers explain why the market didn’t “forgive and forget.” At the top dose (10 mg/kg), the company reported an ~45% reduction in hypoglycemia events—not statistically significant versus the placebo arm, which saw an ~40% improvement. On the key secondary endpoint, the top-dose arm showed an ~25% reduction in time in hypoglycemia, again not statistically significant versus placebo (which increased by ~5%). [3]
In plain English: ersodetug appeared to help, but placebo helped almost as much, and the trial math didn’t clear the bar needed for a clean win.
Why the placebo response mattered (and what management said about it)
Reuters reported that CEO Nevan Elam pointed to a large placebo response as an “inherent problem” in trials involving ultra-rare pediatric populations, where families closely monitor glucose—potentially changing behavior in ways that reduce hypoglycemia events regardless of treatment assignment. [4]
That doesn’t automatically mean the drug doesn’t work. It does mean the specific trial design and endpoints didn’t prove it in the way regulators and markets typically demand—especially for a company that, for investors, is essentially a single-asset story.
Safety wasn’t the headline, but it wasn’t invisible either
Rezolute said safety observations were “generally favorable” in its view, but disclosed that two participants experienced serious hypersensitivity reactions that caused early discontinuation of study drug. [5]
For biotechs, “safety signal” is never a throwaway phrase. Still, the market reaction here was primarily driven by efficacy not separating from placebo, not by a broad safety shutdown.
The market reaction: RZLT cratered, then bounced off the floor
The immediate stock move was violent. Reuters reported shares fell about 89% after the news, and Fierce Biotech described the stock dropping 87% to about $1.40 in early trading, down from a prior close around $10.94. [6]
Since then, the stock has shown sharp reflexive volatility. By the Dec. 23 close, MarketBeat and StockAnalysis both showed RZLT around $2.42, implying a meaningful rebound from the panic lows—though still a fraction of where it traded before sunRIZE. [7]
This is a classic post-data biotech pattern: a cliff, a scramble for “what’s left,” then price discovery as analysts and investors rebuild models with fewer assumptions and more scars.
What remains of the bull case: upLIFT in tumor hyperinsulinism is still alive
Even after sunRIZE, Rezolute isn’t done. The company’s other major late-stage effort is upLIFT, a Phase 3 program evaluating ersodetug in tumor hyperinsulinism (tumor HI), with results expected in the second half of 2026. [8]
Importantly, Rezolute previously announced it achieved FDA alignment on a streamlined path for tumor HI: a truncated, single-arm, open-label Phase 3 study in up to 16 hospitalized participants that FDA considered acceptable as an adequate-and-well-controlled study to support registration—removing the need to run a traditional double-blind randomized placebo-controlled trial. [9]
That streamlined design is a big deal because it potentially reduces:
- time to data,
- cost to run the trial,
- and the “placebo-behavior confounding” risk that management and some analysts believe contributed to sunRIZE.
That said, “smaller and faster” doesn’t mean “easy.” Small-n trials can produce noisy results—and markets typically demand clean outcomes when the entire valuation depends on them.
Regulatory tailwinds still exist: Breakthrough Therapy Designation and Orphan status
Before sunRIZE failed, Rezolute had built meaningful regulatory momentum for ersodetug in hyperinsulinism.
In May 2025, the company announced the FDA granted Breakthrough Therapy Designation (BTD) to ersodetug for hypoglycemia due to tumor hyperinsulinism, citing clinical-trial data across the program plus real-world experience via an Expanded Access Program. [10]
Separately, FDA’s Orphan Drug Designations database shows ersodetug received Orphan Drug Designation for hypoglycemia due to tumor hyperinsulinism (listed with a designation date in 2024). [11]
These designations don’t guarantee approval. But they can speed communication, review processes, and—if the data cooperate—help a small company punch above its weight in a rare-disease setting.
“People are still taking the drug”: the extension-study detail investors noticed
One nuance that keeps coming up in post-sunRIZE commentary: Reuters reported that more than 50 children from the trial continued taking ersodetug in an extension study, with some weaned off other background therapies. [12]
This is not the same as saying “the trial was actually a win.” It does, however, help explain why some analysts retained Buy ratings even while cutting targets hard: they’re betting there may be a subgroup signal, endpoint redesign opportunity, or a cleaner path in tumor HI.
Wall Street resets: analyst downgrades and price-target cuts after sunRIZE
Analyst reactions after pivotal trial failures are often less “one unified verdict” and more “everyone runs different damage-control math.” For Rezolute, the cuts were steep and fast.
Here are the most notable published actions captured in current coverage:
- Craig-Hallum downgraded Rezolute to Hold from Buy and set a $2 price target, explicitly tying the move to the Phase 3 miss in congenital hyperinsulinism. [13]
- Guggenheim kept a Buy rating but cut its price target to $6 from $15, with TheFly/TipRanks reporting the firm eliminated cHI from its model after sunRIZE while reassessing tumor HI assumptions and odds of success. [14]
- BTIG cut its price target to $5 from $17 while maintaining a Buy rating. Investing.com reported BTIG removed cHI from its model and reduced the probability of success for tumor HI (and increased discounting assumptions). [15]
- H.C. Wainwright cut its target to $5 from $14 while maintaining a Buy rating, and Investing.com reported the firm pointed to Rezolute’s cash position as sufficient to reach tumor HI data while revising probability assumptions. [16]
The takeaway for investors is not “pick the nicest target.” It’s that the Street is increasingly valuing Rezolute as a tumor HI option (with a smaller possibility of a cHI salvage path), rather than as a near-term cHI commercialization story.
Snapshot forecasts on Dec. 24, 2025: consensus targets still show huge “upside,” but read the fine print
If you look only at headline consensus numbers, RZLT may appear wildly undervalued—because many data aggregators still reflect targets set before the sunRIZE washout.
- MarketBeat displayed a consensus price target of $9.78 and a consensus rating of Hold (based on its methodology and most recent ratings). [17]
- StockAnalysis displayed an “analyst consensus” of Strong Buy with an average target of $12.33, and it also lists some recent target reductions (including cuts to $6 and $5). [18]
Here’s the practical, investor-relevant reality: after a binary trial failure, consensus target pages can lag while firms update models, publish new notes, or drop coverage. So these “average target” numbers may blend pre-failure optimism with post-failure triage. Treat them as a snapshot of how messy the reset is—not as a clean promise of upside.
Media and independent analysis: what commentators emphasized
Beyond the company release and Wall Street notes, several widely read outlets focused on the same central issue: Rezolute needed sunRIZE to validate its cHI thesis ahead of a potential filing, and it didn’t get that validation.
- Reuters summarized the miss, the high placebo response, and Rezolute’s plan to meet with FDA to discuss next steps, while noting the ongoing tumor HI trial with data expected in 2H 2026. [19]
- Fierce Biotech highlighted that Rezolute had been preparing for commercialization (including hiring commercially oriented leadership) before the miss, underscoring how abruptly the narrative changed. [20]
- Zacks ran bearish post-mortems noting the magnitude of the December drawdown and framing the move as tied to the Phase 3 failure, while also producing “turnaround” style commentary typical of its technical/quant lens. [21]
For a Google News/Discover audience, the key point is this: the market is now trading Rezolute less like a near-approval rare-disease company and more like a high-cash, high-risk biotech with one major remaining clinical catalyst.
Legal headlines: multiple firms announced investigations following the stock drop
Another strand of “current news” around Rezolute since the sunRIZE drop has been a cluster of securities-focused law-firm announcements.
Among the most visible:
- Hagens Berman published an investigation announcement tied to the post-sunRIZE share decline. [22]
- Faruqi & Faruqi issued an “investigation notice” regarding claims on behalf of investors. [23]
- Block & Leviton published an announcement stating it was investigating Rezolute for possible securities fraud after the stock’s sharp decline. [24]
- The DJS Law Group also released an investigation-related announcement referencing the trial failure and stock plunge. [25]
These press releases are not the same as a court ruling or a proven claim; they are part of the typical post-crash ecosystem for volatile biotech names. Still, they can add headline risk and distraction—especially for institutional investors with strict governance screens.
Rezolute’s financial position: cash matters more when the next catalyst is in 2026
One reason Rezolute hasn’t traded to “zero and forgotten” is that the company entered this pivotal moment with substantial cash.
In its Q1 fiscal 2026 update (for the quarter ended September 30, 2025), Rezolute reported $152.2 million in cash, cash equivalents, and investments in marketable securities. [26]
Cash runway matters because the next major data catalyst—upLIFT in tumor HI—is expected in the second half of 2026, meaning investors are underwriting not just clinical risk, but “can they fund operations long enough to get there?” risk. [27]
The bottom line for RZLT stock on Dec. 24, 2025
Rezolute stock (RZLT) is now trading in the shadow of a failed pivotal trial, with a narrative that has pivoted from “near-term cHI filing” to “tumor HI is the remaining path that could still justify the platform.” The latest coverage and forecasts as of December 24, 2025 show:
- a confirmed Phase 3 miss in cHI (sunRIZE), [28]
- a stock that collapsed and then partially rebounded to around the mid–$2 range, [29]
- analysts cutting targets sharply (often keeping Buy ratings but modeling out cHI), [30]
- a remaining pivotal program (upLIFT) with data expected in 2H 2026 and a regulatory tailwind via BTD/Orphan designations, [31]
- and ongoing legal “investigation” headlines that add noise to an already high-volatility setup. [32]
For investors, the rational framing is simple (even if the outcome isn’t): RZLT is a biotech option on 2026 tumor HI data, with everything else—turnaround narratives, consensus-target upside math, and day-to-day squeezes—secondary to whether upLIFT delivers a clean, regulator-ready efficacy story.
References
1. www.marketbeat.com, 2. ir.rezolutebio.com, 3. ir.rezolutebio.com, 4. www.reuters.com, 5. ir.rezolutebio.com, 6. www.reuters.com, 7. www.marketbeat.com, 8. www.reuters.com, 9. ir.rezolutebio.com, 10. ir.rezolutebio.com, 11. www.accessdata.fda.gov, 12. www.reuters.com, 13. www.tipranks.com, 14. www.tipranks.com, 15. www.investing.com, 16. www.investing.com, 17. www.marketbeat.com, 18. stockanalysis.com, 19. www.reuters.com, 20. www.fiercebiotech.com, 21. www.zacks.com, 22. www.prnewswire.com, 23. www.prnewswire.com, 24. www.globenewswire.com, 25. www.businesswire.com, 26. ir.rezolutebio.com, 27. ir.rezolutebio.com, 28. ir.rezolutebio.com, 29. www.marketbeat.com, 30. www.tipranks.com, 31. ir.rezolutebio.com, 32. www.prnewswire.com
